Detection of breast carcinoma is classically determined by examination of a biopsy taken from a patient suspected of carrying such a tumor. These methods are inadequate not only because the patient is subjected to invasive, surgical techniques, but also because the information provided from such a method does not clearly indicate the prognosis of the patient from which the biopsy was taken. Prognosis concerns the likelihood that an individual may suffer occurrence, relapse or distant relapse of cancerous disease. Relapse is the recurrence of tumor growth due to propagation of tumor cells remaining in the host after surgery, new tumor cell development, or the like. Distant relapse concerns tumor dissemination such that tumor growth occurs at a site distant from the site of the original tumor. Of additional interest in the case of disease relapse is the length of the relapse-free survival time. Relapse-free survival time is the period between either surgical removal of the tumor or the suppression or mitigation of tumor growth and the recurrence of cancerous disease. Prognosis may be affected by various criteria such as histological type, tumor grade, tumor size, ploidy, and expression of certain hormone receptors such as estrogen receptor. These criteria provide some guidance in determining the need for and efficacy of subjecting the patient to various cancer therapies, such as irradiation, adjuvant therapy or surgical procedures such as mastectomy.
As an alternative to the more classical methods mentioned above, detection of cancer cell-associated products may find use in detecting the presence of breast carcinoma and in determining the prognosis of patients with breast cancer. Cancer cells synthesize unusual and sometimes highly specific glycolipids, glycoproteins and mucins. In many cases these proteins, glycolipids or mucins, which are produced as a result of aberrant gene expression, are presented on the surface of cancerous cells and may also be secreted or shed from the cell surface. Detection of these cancer-specific components may then serve as a marker for the presence of cancerous cells and also allow for determination of the prognosis of the host carrying the tumor.